U.S. patent number 5,634,931 [Application Number 08/315,249] was granted by the patent office on 1997-06-03 for hernia mesh patches and methods of their use.
This patent grant is currently assigned to Surgical Sense, Inc.. Invention is credited to Robert D. Kugel.
United States Patent |
5,634,931 |
Kugel |
June 3, 1997 |
Hernia mesh patches and methods of their use
Abstract
Surgically implantable hernia mesh patches are available in
several embodiments, wherein each embodiment has double like size
layers of inert synthetic mesh material, compressibly positioning
an internally positioned loop of a resilient monofilament fiber,
when these double layers of mesh are sewn together around their
edges, while leaving one centimeter free of both top and bottom
layers of mesh. During operating time of a surgical repair of an
inguinal hernia, one of these hernia mesh patches is compactively
arranged and then inserted through a relatively small incision, for
subsequent planar expansion and directed placement to where the
hernia is, usually under minimal anesthesia, without the need for
entering a patient's abdominal cavity, and without the need to use
instrumentation, such as laparoscopic equipment. One of the double
layers has a transverse slit for the insertion of a surgeon's
finger between these layers of mesh, which facilitates a surgeon's
maneuvering and positioning of these double layers of mesh, being
always expanded by the loop of resilient monofilament fiber, within
a patient's preperitoneal pocket volume to serve as this surgical
patch without sutures. The other embodiments have very worthwhile
additive features.
Inventors: |
Kugel; Robert D. (Chehalis,
WA) |
Assignee: |
Surgical Sense, Inc.
(Arlington, TX)
|
Family
ID: |
23223548 |
Appl.
No.: |
08/315,249 |
Filed: |
September 29, 1994 |
Current U.S.
Class: |
606/151; 606/1;
606/213 |
Current CPC
Class: |
A61F
2/0063 (20130101); A61F 2002/0068 (20130101) |
Current International
Class: |
A61F
2/00 (20060101); A61B 017/00 () |
Field of
Search: |
;606/151,200,213,1,110,113,114,127 ;623/11 ;128/899 ;602/58 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Buiz; Michael Powell
Assistant Examiner: Schmidt; Jeffrey A.
Attorney, Agent or Firm: Bradley; James E.
Claims
I claim:
1. A hernia mesh patch for use in repairing inguinal and other
abdominal wall hernias for expansion into a preperitoneal space and
direction into a pocket thereof of an abdominal lining, when
directed by a surgeon using his or her finger, after being
compactively arranged for finger insertion through a relatively
small incision, with the patient being usually under minimal
anesthesia, and without the need for entering the abdominal cavity,
and without the need of complicated instrumentation, such as
laparoscopic equipment, comprising:
a. a first layer of inert synthetic mesh material selectively sized
and shaped to extend across and beyond a hernia;
b. a second layer of like material, like size, and like shape of
the first layer;
c. securing means for securing these respective first and second
layers nearby their peripheries creating an interior space, serving
as a pouch, between these first and second layers;
d. the pouch, also called a pocket, located between the first and
second layers of the inert synthetic mesh material, created when
the securing means was used to secure these layers together nearby
their peripheries;
e. wherein one of these layers of inert synthetic mesh material has
a transverse slit for the insertion of a single finger into the
pouch between these layers, which facilitates the maneuvering and
positioning of this hernia mesh patch within a preperitoneal space
and its direction into the pocket thereof located by the
hernia;
f. an internally positioned loop, also referred to as a ring or
spring, of a non-metallic resilient monofilament fiber, which is
compressibly held in the pouch, and thereby creates tension
throughout both layers of the inert synthetic mesh material;
and
g. wherein the first and second layers of inert synthetic mesh
material, also referred to as the top and bottom layers, each have
free outer portions, beyond where the securing means secures them
to create the pouch, which are free to frictionally hold the hernia
mesh patch in place by under the hernia defect.
2. A hernia mesh patch, as claimed in claim 1, wherein free outer
portions are slit to create tab portions thereof to increase their
frictional holding power.
3. A hernia mesh patch, as claimed in claim 2, wherein the tab
portions are scalloped to increase their frictional holding
power.
4. A hernia mesh patch, as claimed in claim 3, wherein the first
and second layers of inert synthetic mesh material, inside where
the securing means secures the first and second layers together,
have spaced aligned openings, which serve to frictionally position
the hernia mesh patch and to accommodate the growth of the
patient's scar tissue, further insuring the intended positioning of
the hernia mesh patch by the hernia.
5. A hernia mesh patch, as claimed in claim 4, wherein the loop,
also referred to as the ring or spring, has spaced spikes, which
contact the patient's tissue, thereby keeping the hernia mesh patch
by the hernia.
6. A hernia mesh patch, as claimed in claim 5, wherein spaced
spikes are each located by respective spaced aligned openings in
the first and second layers of the inert synthetic mesh
material.
7. A hernia mesh patch, as claimed in claim 1, wherein the free
outer portions are fringed to increase their frictional holding
power.
8. A hernia mesh patch, as claimed in claim 7, wherein the first
and second layers of inert synthetic mesh material, inside where
the securing means secures the first and second layers together,
have spaced aligned openings, which serve to frictionally position
the hernia mesh patch and to accommodate the growth of the
patient's sear tissue, further insuring the intended positioning of
the hernia mesh patch located by the hernia.
9. A hernia mesh patch, as claimed in claim 8, wherein the loop has
spaced spikes, which contact the patient's tissue, thereby keeping
the hernia mesh patch located by the hernia.
10. A hernia mesh patch, as claimed in claim 9, wherein the spaced
spikes are each located by respective spaced aligned openings in
the first and second layers of the inert synthetic mesh
material.
11. A hernia mesh patch, as claimed in claim 1, wherein the second
layer of inert synthetic mesh material has portions thereof made of
expanded poly tetra fluoroethylene material, which is used where
adhesion to a patient's abdominal viscera is not wanted.
12. A method of sutureless repair of an inguinal or other abdominal
wall hernia, and in specific respect to sutureless repair of an
inguinal hernia, comprising the steps undertaken by the surgeon
of:
a. cutting an approximately three centimeter incision obliquely
positioned approximately two to three centimeters above the
location described as the internal ring, where the inguinal hernia
has occurred, with this cutting extending through the patient's
skin, subcutaneous fatty tissues, and the external oblique fascia,
which is cut parallel with the fibers thereof a short distance,
exposing the underlying internal oblique muscle;
b. separating portions of the internal oblique muscle to in turn
expose the transversalis fascia;
c. cutting the transversalis fascia creating an entrance into the
preperitoneal space above the peritoneum at a location above the
hernia;
d. identifying and freeing the hernia sac;
e. creating a pocket in the preperitoneal space;
f. obtaining a hernia mesh patch made of a first layer of inert
synthetic mesh material selectively sized and shaped to extend
across and beyond a hernia, and a second layer of like material,
like size, and like shape of the first layer and secured together
nearby their peripheries, creating an interior space, serving as a
pouch between these first and second layers, and having a
transverse slit for the insertion of a single finger of a surgeon
into the pouch, and having an internally positioned loop of a
resilient monofilament fiber compressibly held in the pouch, which
creates tension throughout both layers of the inert synthetic mesh
material;
g. folding and compacting the hernia mesh patch;
b. directing the folded and compacted hernia mesh patch down
through the incision and beyond into the preperitoneal space;
i. expanding the hernia mesh patch in the preperitoneal space by
positioning it so the loop of resilient fiber freely creates the
tension throughout both layers of the mesh material;
j. inserting one finger of a surgeon through the incision and
beyond to the transverse slit and into the pouch of the hernia mesh
patch;
k. directing the hernia mesh patch, by using the finger of the
surgeon, through the preperitoneal space and into the pocket by the
hernia;
l. withdrawing the surgeon's finger from the hernia patch and back
up through the incision; and
m. dosing the incision with stitches.
13. A method of sutureless repair of an inguinal or other abdominal
wall hernia, as claimed in claim 12, wherein in the step of
obtaining a hernia mesh patch includes obtaining a patch having
holes made at spaced locations just inside where the layers of the
mesh material are secured together, whereby the friction is
increased to insure the hernia mesh patch will remain in place, and
whereby subsequently the scar tissue will grow through these spaced
holes.
14. A method of sutureless repair of an inguinal or other abdominal
wall hernia, as claimed in claim 13, wherein the step of obtaining
a hernia mesh patch includes obtaining a patch where the layers of
inert synthetic mesh material at their peripheries beyond where the
layers are secured together are cut to increase their frictional
function in keeping the hernia mesh patch in position located by
the hernia.
15. A method of sutureless repairing an inguinal and other
abdominal wall hernias, as claimed in claim 14, wherein the step of
obtaining a hernia mesh patch, includes obtaining a patch, where
the internally positioned loop of resilient monofilament fiber is
made to include spaced spikes, located at the respective spaced
holes, to penetrate the patient's body tissue, to thereby hold the
hernia mesh patch in position located by the hernia.
16. A method of sutureless repair of an inguinal or other abdominal
wall hernia, as claimed in claim 12, wherein the step of obtaining
a hernia mesh patch includes obtaining a patch where the layers of
inert synthetic mesh material at their peripheries beyond where the
layers are secured together are cut to increase their frictional
function in keeping the hernia mesh patch in position located by
the hernia.
17. A method of sutureless repair of an inguinal or other abdominal
wall hernia, as claimed in claim 12, wherein the step of obtaining
a hernia mesh patch, includes obtaining a patch, where the
internally positioned loop of resilient monofilament fiber is made
to include spaced spikes to penetrate the patient's body tissue, to
thereby hold the hernia mesh patch in position located by the
hernia.
18. A hernia mesh patch for use in repairing inguinal and other
abdominal wall hernias for expansion into a preperitoneal space and
direction into a pocket thereof of an abdominal lining when
directed by a surgeon using his or her finger, after being
compactively arranged for finger insertion through a relatively
small incision, with the patient being usually under minimal
anesthesia, and without the need for entering the abdominal cavity,
and without the need of complicated instrumentation, such as
laparoscopic equipment, comprising:
a. a first layer of inert synthetic mesh material selectively sized
and shaped to extend across and beyond a hernia;
b. a second layer of like material, like size, and like shape of
the first layer;
c. securing means for securing the respective first and second
layers nearby their peripheries creating an interior space, serving
as a pouch, between these first and second layers;
d. the pouch, also called a pocket, located between the first and
second layers of the inert synthetic mesh material created when the
securing means was used to secure these layers together nearby
their peripheries;
e. a substantially complete transverse slit in one of these layers
of inert synthetic mesh for the insertion of a single finger into
the pouch between these layers, which facilitates the maneuvering
and positioning of this hernia mesh patch within a preperitoneal
space and its direction into the pocket thereof located by the
hernia; and
f. an internally positioned flexible loop, also referred to as a
ring or spring, of a non-metallic resilient monofilament fiber,
which is compressibly held in the pouch, and thereby creates
tension throughout both layers of the inert synthetic mesh
material, and this flexible loop is readily handled by a doctor
during surgery to change the loop contour for convenient insertion
through the incision; yet when the hernia patch is in place, the
flexible loop returns quickly to its loop shape.
19. A hernia mesh patch for use in repairing inguinal and other
abdominal wall hernias for expansion into a preperitoneal space and
direction into a pocket thereof of an abdominal lining when
directed by a surgeon using his or her finger, after being
compactively arranged for finger insertion through a relatively
small incision, with the patient being usually under minimal
anesthesia, and without the need for entering the abdominal cavity,
and without the need of complicated instrumentation, such as
laparoscopic equipment, comprising:
a. a first layer of inert synthetic mesh material selectively sized
and shaped to extend across, beyond and under a hernia defect;
b. a second layer of like inert synthetic mesh material, sized, and
shaped to extend across and under a hernia defect;
c. a means to secure these respective first and second layers
together nearby the periphery of the second layer, creating an
interior space, serving as a pouch, between these first and second
layers;
d. the pouch, also called a pocket, located between, the first and
second layers of the inert synthetic mesh materials, created when
these layers are secured together;
e. a substantially complete transverse slit in one of these layers
of inert synthetic mesh for the insertion of a single finger into
the pouch between these layers, which facilitates the maneuvering
and positioning of this hernia mesh patch within a preperitoneal
space and its direction into the pocket thereof located by the
hernia; and
f. an internally positioned flexible loop, also referred to as a
ring or spring, of a non-metallic resilient monofilament fiber,
which is compressibly held in the pouch, and thereby creates
tension throughout both layers of the inert synthetic mesh
material, and this flexible loop is readily handled by a doctor
during surgery to change the loop contour for convenient insertion
through the incision; yet when the hernia patch is in place, the
flexible loop returns quickly to its loop shape.
20. A hernia mesh patch, as claimed in claim 19, wherein the second
layer of like inert synthetic mesh has spaced openings, nearby
where the two layers are secured together, to facilitate tissue
growth into this hernia mesh patch.
Description
BACKGROUND
Surgically implantable mesh patches for the repair of inguinal and
other abdominal wall hernias, which are intended for permanent
placement within a patient's body space, have been provided and
used previously as set forth, for examples, in the following U.S.
patents:
In 1954, Benjamin F. Pease, Jr., in his U.S. Pat. No. 2,671,444
illustrated and described his nonmetallic mesh surgical insert for
hernia repair, comprising a sheet of relatively fine uniform open
mesh work of a durable, permanently pliable, non-toxic radiation
permeable resinous material, which was compatible with body tissues
and fluids, and inert chemically with respect thereto. All the
joints of the mesh work were preferably unitary, in consequence of
which the surgeon could trim the she, of open mesh work to any
desired size and shape, without any danger of it unraveling. The
cut edge provided an adequate strong portion for suturing the mesh
work to the patient's body tissues at any convenient location. The
mesh work itself promoted the ready growth therethrough of the
patient's own repair tissue. The mesh work insert was adapted to
remain permanently in the patient's body, facilitating the body's
own efforts to repair the hernia, and minimizing the chance of
reoccurrence, without the danger of future difficulties because of
irritation, corrosion, or the like.
In 1962, Francis C. Usher in his U.S. Pat. No. 3,054,406,
illustrated and described his improved surgical mesh which was
intended to be held in place by sutures. This surgical mesh was
made of a polyethylene thread, free of water leachable irritant
impurities and having a tensile strength of at least 50,000 p.s.i.,
and a weight from 100 to 500 denier. The threads of the improved
surgical mesh were spaced at intervals in the range of 5 to 50
mils. These threads were unattached to each other at their points
of crossing. This improved surgical mesh was physiologically inert
even in the presence of any possible infection.
In 1982, Francis C. Usher in his U.S. Pat. No. 4,347,847, continued
describing and illustrating his improvements in providing surgical
mesh and the method of the use thereof in hernia repair. In his
method of repairing hernias and other defects of the abdominal and
chest wall, he placed a tubular surgical mesh over the defect in
its flattened form to provide continuous border edges. The tubular
surgical mesh was of a size sufficient to bridge the defect, and to
position the continuous border edges thereof on tissue adjacent the
opposite sides of the defect, free of selvage edges. He then
sutured through the mesh adjacent the continuous border edges to
the tissue. The surgical mesh was comprised of monofilament threads
which were free of water leachable irritant impurities and were
physiologically inert, even in the presence of infection. The
monofilament threads had a tensile strength sufficient, when
doubled, to withstand wound tension. The threads of the mesh had a
diameter in the range of 5 to 15 mils. The mesh was formed having
10 to 20 stitches per inch, and during the formation a continuous
tubular shape was created. The threads were unattached to each
other at their points of crossing. The threads were made of a
polypropylene monofilament.
In 1992, Mark A. Eberbach in his U.S. Pat. No. 5,116,357,
illustrated and described his hernia plug and introducer apparatus.
Mr. F. Eberbach provided, via a laparoscopic system, a plug and
patch assembly comprising a cylindrical plug of flexible material,
positionable in an opening in the abdominal wall to be repaired,
with the plug being in contact with the opening. The plug had a
distal end and a proximal end. Then there was a patch of an
inextensible and flexible mesh material to be positioned over
weakened portions of the abdominal wall adjacent to the opening. A
central extended portion of the patch was coupled to the proximal
end of the cylindrical plug, with the periphery of the patch being
remote from the plug, and constituting a flange. Then a resilient
small cross-sectional diameter adjustable loop of ribbon material,
constructed of surgically antiseptic material, was used to keep the
patch extended in the intended location thereof, both over and
beyond the weakened portions of the abdominal wall. A surgeon using
conventional laparoscopic techniques finally positioned the patch,
after the initial placement of this loop of ribbon material.
Also in 1992, Mark a Eberbach in his U.S. Pat. No. 5,122,155,
illustrated and described another of his hernia repair apparatus
and method of use. His laparoscopic repair of abdominal hernias by
a surgeon, through patching of a weakened portion of the abdominal
part to be repaired, comprised the steps of:
"providing a patch formed of flexible, inextensible material and
positionable in a plane adjacent to the weakened portions of the
abdominal part to be repaired, the patch having an elongated
passageway located in the plane of the patch adjacent to the
majority of the periphery of the patch, the passageway having an
opening at one end thereof;
providing an elongated interior ribbon having a distal end
positioned through the opening of the passageway and slid able
within the passageway, the ribbon being sufficiently rigid whereby
it may be remotely pushed into the passageway;
providing an elongated intermediate cylindrical plunger having an
interior slid ably receiving the ribbon, the plunger having a
distal end coupled to the patch and a proximal end to be
manipulated by the surgeon;
providing an elongated exterior cylindrical sheath having an
interior slid ably receiving the plunger, the ribbon and the patch,
the sheath having a distal end adjacent to the patch and a proximal
end to be manipulated by the surgeon, the sheath being of a length
to extend from exterior of a patient through a laparoscopic port
into a surgical cavity which includes the part to be repaired;
positioning the patch and the distal ends of the ribbon, plunger
and sheath into a patient adjacent to the area to be repaired;
advancing the patch and plunger from the sheath;
advancing the ribbon into the passageway of the patch to expand the
patch;
coupling the patch to the area to be repaired;
withdrawing the ribbon from the patch;
separating the patch from the plunger; and
withdrawing the ribbon, plunger and sheath from the patient."
Also in 1992, Alfredo Fernandez illustrated and described his
prosthetic mesh patch for laparoscopic hernia repair. His mesh
patch, which was inserted through the opening in the patient to be
repaired, was a rolled up sheet of surgical plastic mesh maintained
in a rolled up form by attaching at least two bands around it. Then
he made multiple longitudinal cuts in the first end of this rolled
up mesh to form multiple flared out flaps. The flaps were then
stitched to a planar sheet of plastic surgical mesh. The overall
patch was then inserted into the patient's opening, by using a
second end of the rolled up sheet of surgical plastic. In this way,
the rolled portion of the patch entered the patient's opening, and
the flaps and the planar sheet of plastic surgical mesh were
displayed out over an entrance to the patient's opening. Thereafter
the planar sheet of plastic surgical mesh was stapled to adjacent
tissue of the patient to retain the patch in position; and
In 1993, Arnold S. Seid in his U.S. Pat. No. 5,254,133 illustrated
and described his surgical implantation device and related method
of use to seal an enlarged, generally circular opening in the wall
of one of the patient's body cavities. He provided a surgical
implantation device having a generally planar first portion and
second portion which were interconnected by a connecting segment.
He then inserted and located one end of a surgical tube through the
patient's wall opening and adjacent a first side of the wall. Then
be forced the first portion of the surgical implantation device out
of the surgical tube adjacent the first side of the wall, and
allowed this first portion to automatically assume a planar shape.
Thereafter he forced the connecting segment of the surgical
implantation device out of the surgical tube to be within the wall
opening. Subsequently, he forced the second planar portion of the
surgical implantation device out of the surgical tube adjacent a
second side of the wall, and allowed this second portion to
automatically assume a planar shape. Then he passed a suture
through the first portion, the connecting segment, and the second
portion of the surgical implantation device, and tied off the
suture to attach these three portions together. Finally, he
withdrew the surgical tube from the patient. Resilient members were
respectively attached to either the first of the second portions,
which were initially flexible enough to be folded into the surgical
tube. Thereafter, when they were cleared from the surgical tube,
they unfolded into a planar orientation with their respective first
or second portions.
These inventors in illustrating and describing their patches and
their ways of using their patches, led the way of creating tension
free surgical repairs of hernias using synthetic mesh materials to
bridge and to patch hernia defects. These repairs resulted in both
a decrease in the recurrence rate as well as a decrease in the
amount of a patient's post operative discomfort. Patients
undergoing these more advanced procedures were able and are able to
resume their normal activities sooner. As realized, some of these
earlier inventions are somewhat complicated or are complicated.
Several use some type of a plug or a locating member to fit within
the hernia defect itself. Also many of these earlier inventions
were designed specifically for use in laparoscopic repair of
hernias. Moreover, many of the prior inventions regarded their
suturing to the patient's body tissue. Although these medical
advances are acknowledged for their usefulness and success, there
remained a need or needs for more improvements in the surgical
repair of hernias.
SUMMARY
A hernia mesh patch for use in the sutureless surgical repair of a
patient's inguinal, or other abdominal wall hernias, is available
for relatively low cost and simplified surgical permanent placement
within a patient's body space. This hernia mesh patch has top and
bottom layers of an inert, synthetic mesh, preferably polypropylene
mesh, sewn to each other at approximately one centimeter from their
outer edges. The top layer has a transverse cut or slip opening
into the interior pocket or pouch volume of this patch. Then to
serve a spring function, an implantable inert monofilament fiber,
arranged in an oval, ovoid, loop, or ring configuration, having a
circumference slightly greater than the circumference of the
interior pocket volume of this patch, is inserted into this pocket
to keep the hernia mesh patch expanded under tension in a planar
configuration.
Then without the need for general anesthesia, nor expensive
laparoscopic instrumentation, a surgeon, when repairing an inguinal
hernia, makes a small incision in the patient, approximately three
centimeters long, arranged obliquely, approximately two to three
centimeters above the internal ring location of the inguinal
hernia. Through this small incision, using the muscle splitting
technique, the surgeon performs a dissection deep into the
patient's preperitoneal space, creating a pocket in this space into
which this hernia mesh patch is to be inserted.
Thereafter, the surgeon, using his or her fingers, readily folds
and compacts this hernia mesh patch and directs it through the
incision and into the patient's preperitoneal space, where it
unfolds and expands into its planar configuration, creating a
trampoline effect. Then the surgeon, using just one of his or her
fingers, placed partially through a slit in the top layer of mesh
and into the pocket or pouch between the top and bottom layers of
this hernia mesh patch, conveniently and accurately moves the
hernia mesh patch to cover the defect in the patient's thick
reinforcing lining of his or her abdominal cavity. Thereafter the
surgeon withdraws his or her finger and then secures the incision
with stitches.
The patient's post-operative discomfort is decreased, and risk of
any recurrence is likewise decreased. The patient's body, soon
after surgery, reacts to the mesh of the hernia mesh patch, and in
a short time, the mesh becomes stuck, thereby keeping the hernia
mesh patch in place. Thereafter the patient's scar tissue grows
into the mesh over a period of time, between thirty and sixty days,
to permanently fix the hernia mesh patch in its intended position
over the repaired area, where the hernia was located.
The hernia mesh patches are made in several sizes. Four standard
sizes accommodate ninety percent of the inguinal and abdominal wall
hernias. With respect to repairing inguinal hernias, the most
appropriate size is eight by ten centimeters.
The diameter of the monofilament fiber, which is preferably made
from nylon, polypropylene, or polyester, and arranged to
subsequently serve as a spring, is adjusted in size in respect to
the selected size of the hernia mesh patch to be used. A large
diameter fiber is used in the spring of a larger diameter mesh
patch to make the hernia mesh patch stiffer. While allowing for the
sufficient stiffness to insure the hernia mesh patch will open to
its predetermined overall dimensions, there must be adequate
flexibility to allow this hernia mesh patch to conform to the
patient's uneven body contours and surfaces, and initially to allow
for the folding and compacting of the hernia mesh patch for its
insertion through the small entrance incision. In respect to all
sizes of these hernia mesh patches, the presence of the
monofilament fiber spring also allows for the use of a smaller
diameter mesh fiber, which might otherwise be necessary to provide
the necessary stiffness in a patch not having such a fiber
spring.
In respect to large hernia mesh patches, the spring may include the
winding of two or more monofilament fibers. Also large hernia mesh
patches are initially kept from sliding by using a limited number
of anchoring stitches. They are placed without creating tension,
without significantly increasing a patient's post-operative
discomfort, and without contributing to the strength of the overall
surgical repair of the patient's hernia.
Regarding the one centimeter, initially free outer edges of the
respective top and bottom layers of the mesh material, they are
slit in radial cuts to create scalloped or fringed edges. The
bottom layer flat scalloped edges serve to fill uneven voids in the
patient's tissue surface, which helps to minimize any risk of the
patient's tissue slipping over this patch and allowing the hernia
to recur. The top scalloped edges are folded back and sewn along
the monofilament fiber spring, leaving some portions of their
folded over scalloped edges free to subsequently resist the
migration of this hernia mesh patch, after it has been inserted
into the limited sized preperitoneal pocket or pouch developed by
the surgeon under the patient's hernia defect. The hernia mesh
patch held in its intended shape by the fiber spring completely
fills enough of this pocket to completely extend over and beyond
the patient's hernia defect. After its initial insertion, and
thereafter, the patient's hernia mesh patch is held in position by
the hydrostatic pressures created between the two tissue layers of
fascia above the patch and the peritoneum below the patch.
In respective designs of these hernia mesh patches, small holes are
cut through both layers of the mesh inside the fiber ring, to
increase friction and to minimize the sliding or migration of the
hernia mesh patch, after it is positioned. Also in some designs,
spaced spikes are attached to the fiber spring, or are integrally
formed with the fiber spring to serve as anchors, by entering the
patient's tissue. Also in some designs of these hernia mesh patches
to be used in a location where the patient's peritoneum has been
destroyed, one layer of this patient's hernia patch is made of a
material, such as "Gortex" material, which is less prone to adhere
to a bowel or other intra-abdominal organ.
In respect to all the hernia mesh patches, they have their
simplicity of design and method of insertion. They adequately
underlay a hernia defect by a minimum of two centimeters around the
circumference of the hernia defect, with sufficient rigidity and
with sufficient friction to eliminate or minimize sliding or
migration. When these hernia mesh patches are used, the repair of
inguinal and other abdominal wall hernias are repaired through a
smaller wound or incision, with less tension, less post-operative
discomfort, shorter operating time, and at a potential lower cost
to the patient.
DRAWINGS
FIG. 1 is a schematic partial front view of a patient's body
indicating, in respect to the surgical repair of an inguinal
hernia, where a three centimeter incision is made obliquely
approximately two to three centimeters above the location described
as the internal ring of the hernia, in reference to the location of
an inguinal hernia;
FIG. 2 is a schematic partial diagrammatic cross-sectional view of
a patient's abdominal wall layers showing an inguinal or other
abdominal wall hernia, and where the surgically implantable hernia
repair mesh patch has been correctly positioned in the
preperitoneal created space;
FIG. 3 is a top view of a preferred embodiment of the surgically
implantable hernia repair mesh patch, having anchoring or friction
holes cut through both layers of the mesh, which after the surgical
insertion of the surgically implantable hernia repair mesh patch,
serve to minimize any risk of the mesh migrating or moving once
positioned by a surgeon;
FIG. 4 is similar to FIG. 3, showing how a surgeon's finger is
inserted through a slit, which is made by cutting through only the
top layer of the two layers of mesh used in this surgical hernia
patch, whereby a surgeon's finger, so inserted between these layers
of mesh, then directs the movement of this surgical hernia patch
through the incision and on to the location of the inguinal
hernia;
FIG. 5 is an exploded view of the surgically implantable hernia
repair mesh patch shown in FIGS. 2, 3 and 4, to show the two layers
of the mesh, preferably cut from polypropylene mesh material, and
also to show a resilient monofilament ring, which when located
between the layers of mesh, becomes a resilient spring ring keeping
the surgical hernia patch fully expanded;
FIG. 6 is a transverse cross sectional view of the center of the
preferred surgically implantable hernia repair mesh patch,
illustrated in FIGS. 2, 3, 4 and 5, with the top and bottom layers
shown slightly separated for illustrative purpose, and showing how
some of the bottom mesh materials extending free of the peripheral
stitching are split, forming tab portions of mesh, and showing how
some of the top mesh materials are first folded back and then sewn
in place by the fold, while allowing the remaining split portions
to remain free before use, and later both these top and bottom free
split tab portions, during and after surgery, help in minimizing or
eliminating any risk of the mesh migrating or moving once
positioned by a surgeon;
FIG. 7 is a top view of another resilient monofilament ring, which
becomes the located spring ring, showing how space anchoring
monofilament spikes are secured to this ring or are made integral
with this ring or are made integral with this ring;
FIG. 8 is a top view of another embodiment of the surgically
implantable hernia repair mesh patch, which has the resilient
monofilament ring, illustrated in FIG. 7, placed between the layers
of mesh thereof, and the spaced anchoring monofilament spikes are
extending diagonally upwardly, and they are located, where there
are respective anchoring or friction boles, made through both
layers of the mesh, and the top layer has the slit to accommodate a
surgeon's finger; and
FIG. 9 is a partial top view of another embodiment illustrating a
circular surgically implantable hernia repair mesh patch having the
resilient monofilament spring ring with spikes, spaced anchoring
holes, and irregular cut edges of both the top and bottom layers of
mesh, where they extend beyond the stitching, and also a slit for
receiving a finger of a surgeon.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The Surgical Method of Preparing to Use the Hernia Mesh Patch to
Repair an Inguinal Hernia
The hernia mesh patches 10, illustrated in the drawings, are
surgically permanently implantable within a patient's body space 12
to adequately cover, correct, and repair any inguinal or other
abdominal wall hernias 14. The surgeon has the objective of making
a sutureless repair, by first cutting an approximately three
centimeter incision 16, obliquely positioned approximately two to
three centimeters above the location described as the internal ring
18, where an inguinal hernia 14 has occurred, as shown in FIG. 1.
Then the surgeon working through this incision 16, and using a
muscle splitting technique, dissects deeply into the patient's
preperitoneal space 20, entering slightly superior and posterior to
the patient's hernia defect 14. The surgeon then creates a pocket
22 in the patient's preperitoneal space 20, into which the hernia
mesh patch 10 is inserted, as shown in FIG. 2.
The surgeon in dissecting deeply into the patient's peritoneal
space 20, as indicated in FIG. 2, will have used a sharp instrument
to make the incision or wound 16 through the patient's skin 24, the
subcutaneous fatty tissues 26, and the external oblique fascia 28,
which has been cut parallel with its fibers a short distance. Then
the surgeon has incised the transversalis fascia 32, creating an
entrance into the preperitoneal space 20, above the peritoneum 34
at a location above the hernia 14. In so doing, the surgeon has
identified and freed up the hernia sac and has created the pocket
22 in the preperitoneal space 20. This space 20 underlies the area
referred to as Hesselbach's triangle, in reference to both indirect
and direct hernias. The surgeon's placement of this hernia mesh
patch 10, using this method, protects the entire inguinal floor,
and therefore not only will it repair or correct a single small
hernia, but will also protect against future hernias through other
potentially weakened areas. In a similar way, a hernia mesh patch
10, sandwiched between a hernia 14, i.e. defect 14, and the inner
lining 34, i.e. the peritoneum 34, of the abdominal cavity 36, is
used to underlay a femoral canal area, not shown, through which
femoral hernias occasionally occur. Wherever used, the hernia mesh
patch 10, in its respective embodiments, serves as the basis for
tension free surgical repair of a hernia, as it is used to patch
and to bridge the hernia 14, i.e. the defect 14. The hernia mesh
patch 10 is made, so after completing this preparation, the surgeon
using his or her fingers, can fold and compact the hernia mesh
patch 10 and insert it down through the incision 16 into
preperitoneal space 20. Thereafter, using his or her finger, the
surgeon expands, moves, and directs, the hernia mesh patch 10 into
position in the pocket 20 within the preperitoneal space 20 to
bridge the hernia 14, or defect 14.
The Hernia Mesh Patches, Compactly Folded and Inserted Through the
Patient's Incision, and Then Expanded, Moved, and Directed, by a
Surgeon Using His or Her finger, Into a Position to Patch and to
Bridge the Hernia
An embodiment 40 of these hernia mesh patches 10, is illustrated in
FIGS. 2 through 6, which is particularly designed for the repair of
an inguinal hernia 10. This embodiment 40 is coraposed of two
similarly sized and shaped pieces 42, 44, of an inert synthetic
mesh material 46, which preferably is a polypropylene material.
This mesh material 46 is formed from monofilament material which is
resistant to infection, and which has been used safely in many
hernia operations, in previous ways and in previous embodiments.
Preferably, the two similarly sized and shaped pieces of mesh
material 42, 44 are made in respective circle, loop, ovoid, or oval
shapes. One 42 of these pieces 42, 44, is referred to as the first
or top layer 42 of the synthetic mesh material 46 and the other one
44 of these pieces 42, 44, is referred to as the second or bottom
layer 44 of the synthetic mesh material 46. These two layers 42,
44, are sewn to each other approximately one centimeter in from
their outer edges 48, 50 using a thread 51 of inert synthetic
material. The outer one centimeter of mesh material 52 of the
bottom mesh material piece or layer 44 is left free to serve as an
apron 54 to fill uneven voids in the patient's tissue. The outer
one centimeter of mesh material 52 of the top mesh material piece
or layer 42 is folded back and sewn adjacent the fold 56, while
leaving free the remaining portions of this outer one centimeter of
mesh material 52 of this top mesh layer 42. Thereafter, this free
portion 57, when the hernia mesh patch 10 has been placed in the
preperitoneal space, serves to frictionally keep this patch 10 in
its hernia 14 repair position. Also inside of the fold 56, like
size holes 59, aligned one above the other, are cut respectively in
the top and bottom mesh layers 42, 44. The presence of these holes
59 helps initially to frictionally keep the hernia mesh patch 10 in
place. Thereafter the patient's scar tissues grow in and around
these holes 59 to continue to keep the hernia mesh patch in
position. The outer one centimeter of mesh materials 52 are both
cut or slit 58, radially or diagonally creating scalloped or
fringed edges 60 on respective flap, or tab portions 62, of both
the outer one centimeter of mesh materials 52, of the top and
bottom mesh layers 42, 44.
Also the top mesh material, or top layer piece 42, is cut or slit
66 transversely at the center 68 thereof, creating a finger access
66 into the interior space 70, or pouch 70, between the top and
bottom layers 42, 44 of the synthetic mesh material 46. Through
this slit 66, a ring like arrangement 72 of a continuous, inert,
implantable, monofilament fiber 74, when squeezed temporarily to
narrow it and to elongate it, is inserted into the interior space
70 or pouch 70. Then it is released, and allowed to expand, serving
a spring function and therefore it is called a spring 72, while it
is compressibly held in this interior space 70 or pouch 70 of the
hernia mesh patch 10, thereby keeping this patch 10 fully extended
in a planar arrangement, as shown in FIGS. 2, 3, and 4. This spring
72 is made of a synthetic material, such as nylon, polypropylene,
or polyester. In each embodiment, this monofilament loop, ring or
spring 72, has a circumference which is slightly larger than the
circumference of the interior space 70, or pocket 70, or pouch 70,
which is formed between the top and bottom layers 42, 44 of the
synthetic mesh material 46.
Another embodiment, i.e. a second embodiment 78, is illustrated in
FIGS. 7 and 8, wherein the ring or spring 80 has spaced
monofilament spikes 82 secured to the ring 80, or made integrally
with it. They are directed on an angle to extend above this
embodiment 78 of a hernia mesh patch 10, to enter the patient's
body tissue. In this way the continuing accurate location of this
hernia mesh patch 10 is insured. The outer one centimeter of mesh
material 52, as shown in FIG. 8, is not cut nor slit.
Another embodiment, i.e. a third embodiment 86, is illustrated in
FIG. 9, wherein a portion of it is shown, indicating its similarity
to the second embodiment 78, illustrated in FIGS. 7 and 8. However,
the outer one centimeter of mesh materials 52 are cut to create
scalloped or fringed circumferential edges 88, above and below,
which also serve to frictionally hold the hernia mesh patch 10 in
place, along with the spikes 82 on the loop, ring or spring 80.
These hernia mesh patches 10 in their various embodiments are made
in several sizes. Generally four standard sizes accommodate ninety
percent of the inguinal and abdominal wall hernias. Inguinal
hernias are generally repaired by using a hernia mesh patch 10,
which is eight centimeters wide and ten centimeters long.
The Surgical Method is Continued Using a Selected Embodiment of the
Hernia Mesh Patch
At the conclusion of the surgeon's use of both sharp and blunt
instruments to create the pocket 22 in the preperitoneal space 20,
he or she selects the type and size embodiment of the hernia mesh
patch 10 best suited to be used in the repair of the patient's
defect or hernia 14. The selected embodiment 40, 78 86 or another
one, not shown, of the hernia mesh patch 10, is folded and further
compacted, as may be necessary, by the surgeon using his or her
fingers, so the selected patch 10 may be conveniently inserted
through the wound or incision 16 and down into the preperitoneal
space 20. In this space 20, the hernia mesh patch 10 is freed and
allowed to expand under the force of the loop, ring, or spring 74.
Thereafter the surgeon using his or her finger, continues any
further expansion of this patch 10, which might be necessary. Then
his or her finger is inserted through the cut or slit 66 in the
center 68 of the top mesh layer 42, and the hernia mesh patch 10
through the preperitoneal space to the pocket 22. After the
withdrawal of his or her finger, the surgeon completes the repair
surgery by closing the wound or incision with stitches, in respect
to this repair of an inguinal hernia, using the remote incision 16,
as illustrated in FIG. 1.
In the repair of other hernias, and especially those that are
large, a direct incision is made, and after the placement of a
large hernia mesh patch 10, the surgeon may use limited sutures to
keep the larger hernia mesh patch 10 in place. Generally, most of
the embodiments of this hernia mesh patch 10 are positioned, and so
remain, without the use of limited sutures.
In respect to the utilization of all of the embodiments of these
hernia mesh patches 10, they have their simplicity of manufacturing
design and of their surgical method of insertion. All these patches
10 adequately underlay a hernia 14 or defect 14, with a minimum of
two centimeters of a surrounding underlay about the circumference
of the hernia 14. They do so, with sufficient rigidity and with
sufficient friction, to eliminate or minimize sliding or migration.
When these hernia mesh patches 10 are used by a surgeon, the repair
of a patient's inguinal hernia 14, or of another abdominal wall
hernia 14, is repaired through a smaller wound or incision 16, with
less surgical tension, less post-operative patient discomfort,
shorter operation time, and at a potential lower cost to the
patient.
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